NEW STUDY INVOLVING 10 CANADIAN RESEARCH SITES SHOWS HIGH CURE RATES FOR GENOTYPE 1 HEPATITIS C USING NEW BRISTOL-MYERS SQUIBB ALL-ORAL DACLATASVIR TRIO FIXED-DOSE COMBINATION
• All-oral, 12-week treatment in UNITY-2 trial achieves 98% cure rate in treatment-naïve and 93% in treatment-experienced patients with cirrhosis when used with ribavirin and 93% and 87% respectively without using ribavirin.
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Ten Canadian research sites were among those that participated in a study whose results announced this week show high cure rates for patients with genotype 1 hepatitis C, including those with cirrhosis, after a 12-week regimen of the new Bristol-Myers Squibb all-oral daclatasvir (DCV) TRIO regimen– a fixed-dose combination of daclatasvir with asunaprevir (ASV) and beclabuvir (BCV) treatment
The UNITY-2 study showed sustained virologic response 12 weeks after treatment (SVR12) among 98% of treatment-naïve and 93% of treatment-experienced cirrhotic patients with ribavirin and 93% of treatment-naïve and 87% of treatment-experienced cirrhotic patients without ribavirin.
The results were presented at The Liver Meeting® 2014, the Annual Meeting of The American Association for the Study of Liver Diseases (AASLD), in Boston, Massachusetts.
“These are a very positive results, particularly as we see high rates of viral eradication in patients with cirrhosis who are normally very difficult to treat, even with treatment regimens twice as long at 24 weeks,” said Dr. Alnoor Ramji, Clinical Associate Professor of Medicine in the Division of Gastroenterology at the University of British Columbia, and one of the Canadian investigators who participated in the study. “The daclatasvir TRIO shows tremendous promise in achieving a cure over a shorter period of time, which should promote treatment adherence.”
Study Design and Results
The Phase III UNITY clinical trial program is an ongoing study investigating 12-week regimens of the DCV-TRIO fixed-dose combination (daclatasvir 30 mg plus asunaprevir 200mg plus beclabuvir 75 mg) in non-cirrhotic and cirrhotic genotype 1 patients.
The open-label UNITY-1 study evaluated a 12-week regimen of the DCV-TRIO without ribavirin in treatment-naïve and -experienced non-cirrhotic patients. Non-cirrhotic treatment-naïve patients (n=312) and treatment-experienced patients (n=103) received the DCV-TRIO fixed-dose combination in one pill twice daily for 12 weeks, with 24 weeks of follow-up. The majority of the patients (73%) were genotype 1a, and 91% of all patients achieved SVR12. 92% of treatment-naive patients and 89% of treatment-experienced patients achieved cure, without the use of ribavirin.
In the UNITY-2 study, both cirrhotic treatment-naïve and treatment-experienced patients received the DCV-TRIO fixed-dose combination, one arm without ribavirin (n=102) and one with ribavirin (n=100). The study was double-blinded to ribavirin, and the majority of the patients (74%) were genotype 1a. The study showed 96% of all patients who received DCV-TRIO with ribavirin achieved SVR12, and 90% of those who received DCV-TRIO without ribavirin achieved SVR12.
In both UNITY-1 and UNITY-2 there were low rates of adverse events (AEs) leading to discontinuation and of serious adverse events (SAEs) overall. In UNITY-1 there were 7 SAEs, all considered not related to study treatment and 3 AEs leading to treatment discontinuation. The most common AEs were headache (25.8%) and fatigue (16.6%). In UNITY-2, there were 3 SAEs related to treatment and 4 AEs leading to discontinuation. The most common AEs were headache and fatigue (both 19.8%).
About Hepatitis C
Hepatitis C is a virus that infects the liver and is transmitted through direct contact with infected blood and blood products. Up to 90 percent of those infected with hepatitis C will not spontaneously clear the virus and will become chronically infected. According to the World Health Organization, up to 20 percent of people with chronic hepatitis C will develop cirrhosis; of those, up to 25 percent may progress to liver cancer.
About Bristol-Myers Squibb Canada
Bristol-Myers Squibb Canada is an indirect wholly-owned subsidiary of Bristol-Myers Squibb Company, a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information, please visit www.bmscanada.ca.